As medical software to treat, diagnose, cure or prevent disease becomes more developed, Korean regulators are increasingly approving clinical trials of such Software as a Medical Device (SaMD) technologies.
Last year, the country’s Ministry of Food and Drug Safety approved 21 SaMD trials of software medical devices, up from just six in 2018. The devices tested last year employed software for diagnosing cancer and other diseases and for analyzing medical images. At least nine separate Korean firms are actively developing such software for a wide range of uses.
The popularity of SaMD technology is driven by an increasing focus in the healthcare field on prevention over treatment. Software driven devices, and the data they are able to analyze rapidly, make prevention and early diagnosis easier.
In many cases, renewals have become very similar to new registrations.
The country’s medical device regulatory system was first established in 2012, replacing a system of voluntary registration that had prevailed in Malaysia until then. After a years-long period of transition, the first mandatory device licenses were issued in July, 2016.